MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH TANGO OPTIMO; AUTOMATED BLOOD BANK ANALYSER SYSTEM

Catalog Number 848 900 010

Device Problems Bent (1059); Component Falling (1105); Device Displays Incorrect Message (2591)

Patient Problem Bruise/Contusion (1754)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

This is our combined initial and final report on this incident.

Event Description

The customer reported that she scratched her hand while trying to retrieve the wash station cap from inside the instrument.The customer had just completed maintenance when she received the incubator loader error.The customer then troubleshot the issue, adjusted the incubator loader and re-initialized.After the system initialized the reagent probe crashed into a reagent bottle and bent the needle.The customer stated that she attempted to straighten the needle to continue.When she was putting the covers back on to the instrument, the cap for the wash station fell off.The customer then attempted to retrieve the cap by reaching into the machine.The tango optimo was switched off during this attempt.While doing so, she scratched her hand.Upon inquiries, the customer states that the scratch is harmless and her hand is fine.Our field service engineer was not able to confirm or duplicate the reported problem.The incubator loader was tested and had no problems.The bent needle was replaced.The instrument is running within its specifications.The customer was not qualified enough to do the troubleshooting.

• Brand Name: TANGO OPTIMO
• Type of Device: AUTOMATED BLOOD BANK ANALYSER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303 ; 103 3130 5
• MDR Report Key: 5580350
• MDR Text Key: 43637788
• Report Number: 9610824-2016-00019
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 848 900 010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1